BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/125 DEG TI CANN TFNA 440MM/RIGHT - STERILE

    MDR report key: 9959454 · Received April 14, 2020

    Report

    Report Number
    8030965-2020-02851
    Event Type
    Injury
    Date Received
    April 14, 2020
    Report Date
    March 20, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819650442
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. VISUAL INSPECTION: THE TFNA FEM NAIL Ø11 R 125° L440 TIMO15 (P/N: 04.037.134S LOT #: 9903122) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DEVICE WAS BROKEN THROUGH THE WALLS OF THE HELICAL BLADE OPENING OF THE NAIL. A DRILL MARK WAS NOTED TO THE DEVICE. THERE WERE SCRATCHES ON THE DEVICE WHICH HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE THE RELEVANT DRAWING ARE REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED. COMPLAINT CONFIRMED? YES, THE DEVICE RECEIVED WAS BROKEN. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION WAS CONFIRMED FOR THE 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE (P/N: 04.037.134S LOT #: 9903122). THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. PIE-1445926; PIA-1451581 WAS LAUNCHED PREVIOUS TO THIS COMPLAINT TO INVESTIGATE TFNA NAIL BREAKAGE AND ASSOCIATED DRILL MARKS/DAMAGE AT THE HEAD ELEMENT HOLE/BLADE APERTURE. PLEASE SEE PIE-1445926 FOR FURTHER INFORMATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. DEVICE HISTORY LOT MANUFACTURING LOCATION: MONUMENT MANUFACTURING DATE: OCT 02, 2015, EXPIRATION DATE: SEP 01, 2025, PART NUMBER: 04.037.134S, 11MM/125 DEG TI CANN TFNA 440MM/RIGHT- STERILE, LOT NUMBER: 9903122 (STERILE), LOT QUANTITY: 6. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN PROCESS / INSPECT DIMENSIONAL / FINAL, NS063040 REV B MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, TFNA ASSEMBLY INSPECTION NS067861 REV A MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG LPPF, LMD/LPF REV AB WAS REVIEWED AND DETERMINED TO BE CONFORMING. SCN 11793 SUPPLIED BY ETHICON (ABQ) WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART NUMBER: 04.037.912.2, LOCK PRONG, 125 DEGREE, TFNA, BP55 , LOT NUMBER: 9486524, LOT QUANTITY: 96, PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 04.037.912.4, WAVE SPRING, SHIM ENDED, BP55, LOT NUMBER: 7840792, LOT QUANTITY: 982. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION, NS062851 REV B MET ALL INSPECTION ACCEPTANCE CRITERIA. MATERIAL CERTIFICATION AND CERTIFICATE OF CONFORMANCE AND QUALITY HISTORY CARD RECEIVED FROM SMALLEY DATED 02-APR-2015 WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART NUMBER: 04.037.912.3, TFNA LOCK DRIVE, BP58, LOT NUMBER: 9878696, LOT QUANTITY: 80. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, NS062925 REV D MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21127, TIMOAGRI16.00, BP80, LOT NUMBER: 7728706, LOT QUANTITY: 1,600 LBS. PRODUCT CERTIFICATION SUPPLIED BY DYNAMET DATED JUN 12, 2014 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED JUN 25, 2014 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING / PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. DEVICE HISTORY REVIEW. APR 07, 2020: DHR REVIEWED THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THE REMAINING PORTION OF THE BROKEN DISTAL SCREW WAS LEFT INSIDE THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT TREATMENT ON (B)(6) 2019 FOR SUB-TROCHANTERIC FRACTURE USING A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA). DELAYED UNION WAS IDENTIFIED ON (B)(6) 2019. ON (B)(6) 2020, IT WAS DETERMINED THAT THE NAIL WAS BROKEN. REVISION SURGERY TOOK PLACE ON(B)(6) 2020. CONCOMITANT DEVICES: LOCKING SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), TFNA END CAP (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), TFNA FENESTRATED SCREW (PART: 04.038.195, LOT: H582148, QUANTITY: 1). THIS REPORT IS FOR A 11MM/125 DEGREE TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421485 11MM/125 DEG TI CANN TFNA 440MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 9903122 07611819650442

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TFNA SCR PERF L95 TAN| UNK - END CAPS: TFNA| UNK - SCREWS: LOCKING